Multi-centre Randomized Controlled Trial of angiotensin converting enzyme inhibitor (ACEi) /angiotensin receptor blocker (ARB) - withdrawal in chronic kidney disease – STOP-ACEi-STUDY (SAS)

慢性肾脏疾病（CKD）影响英国十分之一的成年人，描述了肾脏功能在数月或数年内的进行性丧失，无论最初的肾脏疾病如何。CKD可能对受影响的患者产生严重影响，包括CKD进展为完全肾衰竭的风险，因此受影响的患者需要通过透析治疗或肾移植来替代肾功能。肾脏疾病是昂贵的，医疗保健预算的很大一部分花在CKD患者身上;仅透析治疗的费用就约为30，000英镑/年。患者的生活质量可能很差，透析会导致早期死亡。治疗高血压（BP）是最重要的干预措施，可以减缓CKD向完全肾衰竭的进展。一些CKD患者从血管紧张素转换酶抑制剂（ACEi）或血管紧张素受体阻滞剂（ARB）药物中获得额外的保护。这些药物治疗高血压，但也通过改变肾脏压力来减缓CKD进展。这也可能影响导致肾功能下降的激素途径。然而，最近的研究表明，在一些患有晚期CKD（4期和5期）的人中，他们正在进展到完全肾衰竭并接受ACEi和/或ARB治疗，停止这些药物会导致肾功能的稳定和改善，并减少或延迟透析治疗的需要。这表明，在某些患者中，用于保护肾脏的片剂可能会通过某些目前未知的机制导致其功能的有害下降。迄今为止，关于这一点的研究是观察性的，为了证实停止这些药物与肾功能稳定之间的关联，需要进行一项研究，比较一组已经停止这些药物的人与一组继续使用药物的人的结果。这被称为随机对照试验（RCT）。在STOP-ACEi试验中，我们将随机分配合适的受试者（随机）继续或停止ACEi/ARB治疗，然后对这些受试者进行3年随访。在这种治疗策略可以投入常规临床实践之前，需要进行这项研究。此外，我们还将研究停用这些药物的其他影响，如对心脏病发作、中风和参与者生活质量的影响。

Chronic kidney disease (CKD) affects 1 in 10 adults in the UK and describes progressive loss of function of the kidneys over a period of months or years regardless of the original kidney disease. CKD can have serious implications for those affected including a risk of CKD progressing to complete kidney failure so that the affected person requires replacement of kidney function by dialysis treatment or kidney transplantation. Kidney disease is expensive with a high proportion of the health-care budget spent on people with CKD; the cost of dialysis treatment alone is ~£30,000/year. Patient quality of life can be poor, with dialysis leading to early death. Treating high blood pressure (BP) is the most important intervention that can slow progression of CKD to total kidney failure. Some people with CKD gain additional protection from drugs called Angiotensin Converting Enzyme inhibitors (ACEi) or Angiotensin Receptor Blockers (ARBs). These drugs treat high BP but also slow CKD progression by changing the pressure in the kidney. This may also influence hormone pathways that contribute to the decline of kidney function. However recent research suggests that in some people with advanced CKD (stages 4 & 5) who are progressing to complete kidney failure and are receiving treatment with an ACEi and/ or ARB, stopping these drugs leads to stabilization and improvement of kidney function and decreases or delays the need for dialysis treatment. This indicates that in some patients the very tablets that are being used to protect the kidneys may be contributing to a harmful decline in their function by some currently unknown mechanism. To date, the research on this is observational and to confirm the association between stopping these drugs and stabilization of kidney function requires a study to compare the outcomes of a group of people who have had these drugs stopped with a group who continue on the drug. This is called a randomised controlled trial (RCT). In the STOP-ACEi trial we will randomly allocate suitable participants (by chance) to either continue or to stop their ACEi/ARB treatment and then to follow-up these participants for 3-years. This study is needed before this treatment strategy can be put into routine clinical practice. In addition we will look at other effects of stopping these drugs such as effects on heart attacks, strokes and participant quality of life.